| CTRI Number |
CTRI/2024/01/061823 [Registered on: 24/01/2024] Trial Registered Prospectively |
| Last Modified On: |
17/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Screening
Other (Specify) [carbohydrate rich water given 2hr and 1hr prior to surgery] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ultrasound based volume of fluid remaining in the stomach in pediatric population undergoing elective surgery after fasting for 1 hour and 2 hour after giving carbohydrate rich fluid and clear fluid
|
|
Scientific Title of Study
|
Ultrasound based assessment of Gastric fluid volume in the Pediatric population planned for elective surgery after carbohydrate rich clear fluid fasting and clear fluid fasting for 1 hour and 2 hour:
A Prospective, Randomized, Double Blinded Study
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amrit Kumar Som |
| Designation |
Junior Resident, MD ANAESTHESIOLOGY |
| Affiliation |
Sri Ramachandra Medical Education and Research |
| Address |
Sri Ramachandra Medical Education and Research, Chennai, Tamil Nadu, India
Thiruvallur
TAMIL NADU
600116
India |
| Phone |
9474876282 |
| Fax |
|
| Email |
amritsomooi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aruna Parameswari |
| Designation |
Head of Departmenrt |
| Affiliation |
Sri Ramachandra Medical Education and Research |
| Address |
Sri Ramachandra Medical Education and Research, Chennai, Tamil Nadu, India
Thiruvallur
TAMIL NADU
600116
India |
| Phone |
9840529863 |
| Fax |
|
| Email |
hod.anaesthesiology@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Amrit Kumar Som |
| Designation |
Junior Resident, MD ANAESTHESIOLOGY |
| Affiliation |
Sri Ramachandra Medical Education and Research |
| Address |
Sri Ramachandra Medical Education and Research, Chennai, Tamil Nadu, India
TAMIL NADU
600116
India |
| Phone |
9474876282 |
| Fax |
|
| Email |
amritsomooi@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH,CHENNAI |
|
|
Primary Sponsor
|
| Name |
Amrit Kumar Som |
| Address |
Sri Ramachandra Medical College and Research, SRIHER, Chennai |
| Type of Sponsor |
Other [Amrit Kumar Som] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Amrit Kumar Som |
Sri Ramachandra Institute of Higher Education and Research Porur, Chennai – 600116 |
5th floor, Department of Anaesthesia, Sri Ramachandra Hospital, Sri Ramachandra Institute of Higher Education and Research
Porur, Chennai – 600116
Thiruvallur
TAMIL NADU |
9474876282
amritsomooi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sri Ramachandra Institute of Higher Education & Research Porur, Chennai - 600116 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Carbohydrate rich clear fluid, Glucon-D |
Glucon-D compared with Water |
| Intervention |
carbohydrate rich clear fluid, Glucon-D and clear liquid (Water) |
Administration of predetermined volume (3ml/kg of body weight) of carbohydrate rich clear fluid, Glucon-D and clear liquid (Water) via oral route and subsequently fasting for 1 hour and 2 hour, subsequently doing an ultrasound to measure gastric fluid volume |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1.Age 1-12 years
2.ASA I and II
3.Scheduled for Non-gastrointestinal surgeries under General Anesthesia,fasting at least 6 hours for solids.
|
|
| ExclusionCriteria |
| Details |
1.Parent/Caregiver refusal
2.Inadequate Nil Per Oral status
3.Obesity (BMI ≥ 30 kg/m2)
4.Gastroesophageal Reflux Disorders
5.Diabetes Mellitus
6.Any disease that will impair gastric motility
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Gastric fluid volume in Right lateral position |
1hr and 2 hr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•Quantitative assessment of the risk of aspiration using 3 cutoff values for GFV:1.5ml/kg, 1.25ml/kg and 0.8ml/kg
•Incidence of any adverse event during induction of anesthesia
•Antral CSA
•Qualitative grading of assessment of Gastric Antrum
|
1 hour and 2 hour |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="140" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
28/01/2024 |
| Date of Study Completion (India) |
31/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - on request by email access
- For how long will this data be available start date provided 28-11-2023 and end date provided 31-12-2026?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Administration of
predetermined volume (3ml/kg of body weight) of carbohydrate rich clear fluid
and clear liquid (Water) and subsequently fasting for 1 hour and 2 hour, at the
end of which a Ultrasound Guided assessment of Antral Cross-sectional area in
Supine and Right Lateral position and determination of the Gastric Fluid Volume
will be carried out in the patient. |